The development of medical devices requires rigorous regulatory requirements, careful planning and strategies for commercialization, pursuit for new technology and improvements. While we see various commercially successful medical devices in the market, no comprehensive development model has been published.
Apart from the company size and the market they share, medical devices companies have a very similar strategy to develop and get their products to market. Scientific researches about medical device project and development process are very good references to the product development strategy of the companies and help them to improve and validated their models.
Stanford University’s researchers have studied the process of how medical technology is brought to market. The model developed by Researchers at the Stanford University Program in Biodesign divides the development in six phases:
“PREDEVELOPMENT, PHASE 0”
The clinical need must me identified and understood by the inventors and devices companies, this phase can be achieved, by direct observations, talking to patients or doctors. A large list of medical needs is made based on market size, clinical impact, and intellectual property.
“PHASE I: INITIATION, OPPORTUNITY AND RISK ANALYSIS”
When the need is identified, a review of all the perspectives is made. Market size, intellectual property, competitive structure, financial resources, regulatory requirements, likewise defining strategies.
“PHASE II: FORMULATION, CONCEPT AND FEASIBILTY”
Concept definition and feasibility take place in this phase, as well as strategies definitions. To accomplish the concept definition, both brainstorming sessions and 3D CAD occur. It is frequent to see the team’s marketing and the team’s R&D meeting with potential users (doctors, nurses, technicians, patients and others) to catch the clients’ attention. In addition, in Phase II we see the team of devices companies defining and analyzing the risks that can happen during the project.
“PHASE III: DESIGN AND DEVELOPMENT, VERIFICATION AND VALIDATION”
In this phase, the team creates a test to verify and validate the concept, although the tests only occur in Phase IV. These tests involve both engineering and quality tests. Many steps of this phase are conducted and reviewed by members of clinical regulatory departments, including FDA (in the USA). Likewise, the production of documentary records.
“PHASE IV: FINAL VALIDATION AND PRODUCT LAUNCH PREPARATION”
Final validation, final product design and regulatory approval take place in this part of the process that brings medical devices to market. Final product design must conform to ergonomics standards. Quality system starts working to define, document and approve the business, which contains both product and administrative perspective.
“PHASE V: PRODUCT LAUNCH AND POST-LAUNCH ASSESSMENT”
Before the launch, doctors will have received training to use the new device. Once it has been approved that the medical device is successful, both launch and distribution will take place. With the new device been used widespread, literature and indications of use are made and approved by FDA (in the USA). R&D has a main role in this phase since the device requires continuing improvements.
Stanford University Program in Biodesign research was based in more than 80 experts in the private and public sectors, including industry representatives and FDA officials.
Biokyra follows its own product development process that is generically very similar to Stanford Model. Each country has its own regulatory system so that the product development process should adapt to those particularities.